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Iambic Therapeutics, a clinical-stage biotech company founded in 2020 and based in San Diego, is seeking a Senior or Executive Director to lead Analytical Development and Quality Control (QC) within Chemistry, Manufacturing, and Controls (CMC). This leadership role provides scientific, strategic, and operational oversight of analytical activities across Iambic's small-molecule drug portfolio, spanning early clinical development through late-stage development and commercialization.
Key responsibilities include: leading drug substance and drug product analytical strategy covering characterization, impurity and degradation-product control, reference standards, comparability, and stability assessments; overseeing analytical method development, validation, transfer, and lifecycle management to ensure methods are fit-for-purpose and regulatory-aligned; managing QC testing, data review, out-of-specification investigations, deviations, root-cause analysis, and corrective/preventive actions; establishing scientifically justified specifications and acceptance criteria; providing analytical leadership for dissolution and product-performance testing; managing the outsourced analytical and QC network including partner selection and performance oversight; ensuring analytical activities support program timelines and manufacturing readiness through cross-functional collaboration; leading CMC support for global regulatory submissions and health authority interactions, including authoring Module 3 content and responding to regulatory queries; and recruiting, developing, and coaching team members while managing functional budgets.
Required qualifications: Ph.D. in Analytical Chemistry or related field with 12+ years pharmaceutical/biotech experience (or M.Sc. with 14+ years, or B.Sc. with 17+ years); extensive hands-on experience in analytical method development, transfer, troubleshooting, and validation for small-molecule drug substance and drug product across development stages; strong experience developing phase-appropriate analytical control strategies; demonstrated experience supporting IND/IMPD and preferably NDA/MAA regulatory filings; proven success leading analytical activities through external CDMOs; in-depth knowledge of cGMP operations and ICH guidance; strong experience with enabling formulations and conventional oral solid dosage forms; proven leadership building collaborative, high-performing teams; excellent written and verbal communication skills; and ability to travel up to 15% domestically and internationally.
